A Study of IO103 in Montanide Adjuvant for Basal Cell Carcinoma
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|ClinicalTrials.gov Identifier: NCT03714529|
Recruitment Status : Recruiting
First Posted : October 22, 2018
Last Update Posted : November 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Basal Cell Carcinoma||Biological: PD-L1||Phase 2|
10 patients with BCC will be vaccinated with a peptide derived from the immune checkpoint molecule PD-L1. Patients will be vaccinated once every 2 weeks (Q2W) for 10 weeks and then evaluated for a clinical response.
Patients with clinical response to vaccination will continue with one vaccination once every 4 weeks (Q4W) for 12 weeks and thus receive 9 vaccinations in total over the course of 22 weeks.
Patients with no effect of treatment after 6 vaccinations will be treated with standard of care (SOC).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase IIa Trial With PD-L1 IO103 Vaccination With Montanide in Patients With Basal Cell Carcinoma|
|Actual Study Start Date :||November 1, 2018|
|Estimated Primary Completion Date :||January 15, 2019|
|Estimated Study Completion Date :||July 15, 2019|
Experimental: Treatment arm
The vaccine consists of 500µl of 100µg PD-L1 peptide, dissolved in DMSO and PBS reconstituted with 500 µl Montanide ISA-51.
Patients will be vaccinated Q2W for 10 weeks, and a further 12 weeks if a clinical response is measured.
IO103 is a anti-cancer therapy consisting of a synthetic PD-L1-derived peptide.
Other Name: IO103
- Disease control rate [ Time Frame: After 6 vaccinations (10 weeks) ]Defined as a reduction in the largest diameter of target BCC measured in millimetres (mm) as well as clinical photographs
- Immune responses [ Time Frame: After 6 vaccinations (10 weeks) ]Blood samples and Tumor biopsy samples (3-4 mm in size) for bioanalysis of programmed death ligand 1 (PD-L1) specific responses
- Immune responses in skin [ Time Frame: After 6 vaccinations (10 weeks) ]Skin-infiltrating lymphocytes (SKILs) will be grown to test for PD-L peptide specificity
- Incidence of treatment emergent adverse events (safety and tolerability) [ Time Frame: After 6 vaccinations (10 weeks) ]Events will be recorded and graded using CTCAE version 4.03
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03714529
|Contact: Jeanette Kaae, Dr||+45 38 67 31 firstname.lastname@example.org|
|Contact: Lone Skov, Prof||+45 38 67 32 email@example.com|
|Study Director:||Inge Marie Svane, Prof||Herlev and Gentofte Hospital|